Kidney TransplantPREDIGRAFT2NCT04969757
Use of Predigraft in Kidney Transplant Patients
A study testing Predigraft group in people with Kidney Transplant, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Kidney transplantation is the treatment of choice for end-stage renal disease in terms of morbidity, mortality, and cost-benefit ratio. Graft loss is mainly related to the occurrence of rejection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Predigraft group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Nov 2021to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who received a kidney transplant from a living or a deceased donor and transplanted at least 1 month ago
- Patient over 18 years of age at the time of inclusion
- Stable renal function (glomerular filtration rate>60 mL/min or decision at physician's discretion) at the time of inclusion
- Informed patient with signed consent
- Patient with access to an internet connection with a valid email
- Enrolled in a social security scheme or beneficiary of such a scheme
Who cannot join
- Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant)
- Kidney transplant less than 1 month old
- Lack of recovery of kidney function following renal transplantation
- Patient unable to use the telemedicine tool
- Vulnerable participants (minors, protected adults, prisoners)
- Patient under State Medical Assistance
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of the Use of the Predigraft Platform (a Remote Monitoring Solution for Predicting Kidney Graft Survival) in Kidney Transplant Patients
Kidney transplantation is the treatment of choice for end-stage renal disease in terms of morbidity, mortality, and cost-benefit ratio. Graft loss is mainly related to the occurrence of rejection. Hence the importance of regular monitoring to check that the graft is functioning properly, to adapt immunosuppressive treatments and to check for side effects related to the immunosuppressed state.
In conventional management, the patient is seen at regular intervals (ranging from 2 weeks to 3 months) in the referral transplant centre with recourse to hospitalisation if necessary. In the context of the COVID-19 pandemic, in order to reduce the risks of contamination, teleconsultations have been proposed to replace face-to-face consultations. Predigraft software facilitates remote patient assessment. This software provides an estimate of the probability of renal graft survival at 3, 5 and 7 years of the assessment based on an algorithm developed and validated by the U970 unit (Loupy A et al, BMJ 2019). The software also provides an application for patients allowing secure data transfer (biological analyses, blood pressure, weight). This allows the assessment of the need for additional patient evaluation based on usual monitoring parameters (creatinine, proteinuria) that can be done in the analysis laboratory near the patient's home.
Read more
A first evaluation of the use and acceptability among care professionals has been conducted between April and June 2020 and showed excellent results. It is now necessary to obtain real-life data to evaluate the use of the tool among patients and healthcare professionals and its impact on the organisation of care.
This is a prospective interventional study with minimal risks and constraints on the active file of transplant patients followed in ambulatory care for a period of 12 months.
The objective of this study will be to evaluate the use of the Predigraft platform by kidney transplant patients.
- Conditions
- Kidney Transplant
- Being tested
- Predigraft group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predigraft groupDevice
Patients in the interventional arm will use Predigraft (Class 1 medical device under MDD 93/42/EEC Cibiltech Society) to receive therapeutic education content (videos, facts sheets, short messages, questionnaires), exchange documents with their doctors and interact via messaging with them.
Physicians will be able to calculate their iBox score to predict their patients' allograft survival at 3, 5 and 7 years.
| Study group | Role | What they receive |
|---|---|---|
| Predigraft | Experimental | Patients in the interventional arm will use Predigraft (Class 1 medical device under MDD 93/42/EEC Cibiltech Society) to receive therapeutic education content (videos, facts sheets, short messages, questionnaires), exchange documents with their doctors and interact via messaging with them.
Physicians will be able to calculate their iBox score to predict their patients' allograft survival at 3, 5 and 7 years. Receives: Device: Predigraft group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who have logged on to the Predigraft application at least 3 times
Measured: at 12 months from study inclusion
Secondary outcomes (24)
French version of Functional, Communicative and Critical Health Literacy (FCCHL) scale
For each subscale of the FCCHL, the literacy score can range from 1 (low) to 5 (high). An overall score is calculated from the scores of the three subscales. A score ≤ 4 corresponds to a low level of literacy.
Measured: at inclusion
French version of Functional, Communicative and Critical Health Literacy (FCCHL)
For each subscale of the FCCHL, the literacy score can range from 1 (low) to 5 (high). An overall score is calculated from the scores of the three subscales. A score ≤ 4 corresponds to a low level of literacy.
Measured: at 12 months after inclusion
Connection time
Measured: at 12 months after inclusion
Connection frequency
Measured: at 12 months after inclusion
Time between two connections
Measured: at 12 months after inclusion
Proportion of fonction used
Measured: at 12 months after inclusion
Quality of life evaluating using SF36
Quality of life evaluated using MOS SF36 questionnaire (Medical Outcomes Study - 36-Item Short Form Health Survey). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 assesses different dimensions of feeling healthy and well being using 11 questions.These measures rely upon patient self-reporting.. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). A high score means a better quality of life.
Measured: at inclusion
Quality of life evaluating using SF36
Quality of life evaluated using MOS SF36 questionnaire (Medical Outcomes Study - 36-Item Short Form Health Survey). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 assesses different dimensions of feeling healthy and well being using 11 questions.These measures rely upon patient self-reporting.. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). A high score means a better quality of life.
Measured: at 6 weeks
Quality of life evaluated using SF36
Quality of life evaluated using MOS SF36 questionnaire (Medical Outcomes Study - 36-Item Short Form Health Survey). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 assesses different dimensions of feeling healthy and well being using 11 questions.These measures rely upon patient self-reporting.. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). A high score means a better quality of life.
Measured: at 12 months
Medication adherence
Medication adherence will be evaluation using the Basel Assessment of Adherence Scale Immunosuppression Scale (BAASIS scale). This is a self-assessment scale to evaluate medication adherence.
Measured: at inclusion
Medication adherence
Medication adherence will be evaluation using the Basel Assessment of Adherence Scale Immunosuppression Scale (BAASIS scale). This is a self-assessment scale to evaluate medication adherence.
Measured: at 6 weeks
Medication adherence
Medication adherence will be evaluation using the Basel Assessment of Adherence Scale Immunosuppression Scale (BAASIS scale). This is a self-assessment scale to evaluate medication adherence.
Measured: at 12 months
Proportion of hospitalisations
Measured: at 12 months after inclusion
Proportion of consultations
Measured: at 12 months after inclusion
Proportion of emergency consultations or hospitalisations
Measured: at 12 months after inclusion
Overall survival
Measured: at 12 months after inclusion
Rejection and dialysis free survival
Measured: at 12 months after inclusion
Cumulative incidence of graft rejection
Measured: at 12 months after inclusion
Proportion of patients with deteriorated renal function
Renal function deterioration will be defined as an estimated glomerular filtration rate < 30 ml/min/1.73m2 according to the MDRD equation and/or, a 10% decrease between inclusion and 12 months after inclusion.
Measured: at 12 months after inclusion
Probability of graft survival
Measured: at inclusion
Probability of graft survival
Measured: up to 12 months
Probability of graft survival
Measured: at 12 months
Time from date of graft to date of non-protocol DSA
Measured: up to 12 months post-inclusion
Time from date of graft to date of non-protocol biopsy
Measured: up to 12 months post-inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start23 Nov 2021
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969757
- Sponsor's protocol ID
- APHP210379
- Acronym
- PREDIGRAFT2
- Status last verified
- Apr 2026
- First submitted
- 17 Jun 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of the Predigraft Platform (a Remote Monitoring Solution for Predicting Kidney Graft Survival) in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT04969757
- Acronym / sponsor ID
- PREDIGRAFT2 / APHP210379
- Conditions
- Kidney Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kidney transplantation is the treatment of choice for end-stage renal disease in terms of morbidity, mortality, and cost-benefit ratio. Graft loss is mainly related to the occurrence of rejection. Hence the importance of regular monitoring to check that the graft is functioning properly, to adapt immunosuppressive treatments and to check for side effects related to the immunosuppressed state.
In conventional management, the patient is seen at regular intervals (ranging from 2 weeks to 3 months) in the referral transplant centre with recourse to hospitalisation if necessary. In the context of the COVID-19 pandemic, in order to reduce the risks of contamination, teleconsultations have been proposed to replace face-to-face consultations. Predigraft software facilitates remote patient assessment. This software provides an estimate of the probability of renal graft survival at 3, 5 and 7 years of the assessment based on an algorithm developed and validated by the U970 unit (Loupy A et al, BMJ 2019). The software also provides an application for patients allowing secure data transfer (biological analyses, blood pressure, weight). This allows the assessment of the need for additional patient evaluation based on usual monitoring parameters (creatinine, proteinuria) that can be done in the analysis laboratory near the patient's home.
A first evaluation of the use and acceptability among care professionals has been conducted between April and June 2020 and showed excellent results. It is now necessary to obtain real-life data to evaluate the use of the tool among patients and healthcare professionals and its impact on the organisation of care.
This is a prospective interventional study with minimal risks and constraints on the active file of transplant patients followed in ambulatory care for a period of 12 months.
The objective of this study will be to evaluate the use of the Predigraft platform by kidney transplant patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Predigraft | Experimental | Device: Predigraft groupPatients in the interventional arm will use Predigraft (Class 1 medical device under MDD 93/42/EEC Cibiltech Society) to receive therapeutic education content (videos, facts sheets, short messages, questionnaires), exchange documents with their doctors and interact via messaging with them. Physicians will be able to calculate their iBox score to predict their patients' allograft survival at 3, 5 and 7 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient who received a kidney transplant from a living or a deceased donor and transplanted at least 1 month ago
- Patient over 18 years of age at the time of inclusion
- Stable renal function (glomerular filtration rate>60 mL/min or decision at physician's discretion) at the time of inclusion
- Informed patient with signed consent
- Patient with access to an internet connection with a valid email
Key exclusion criteria (6 listed)
- Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant)
- Kidney transplant less than 1 month old
- Lack of recovery of kidney function following renal transplantation
- Patient unable to use the telemedicine tool
- Vulnerable participants (minors, protected adults, prisoners)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predigraft groupPatients in the interventional arm will use Predigraft (Class 1 medical device under MDD 93/42/EEC Cibiltech Society) to receive therapeutic education content (videos, facts sheets, short messages, questionnaires), exchange documents with their doctors and interact via messaging with them. Physicians will be able to calculate their iBox score to predict their patients' allograft survival at 3, 5 and 7 years. | Device | Predigraft |
Primary outcome
Proportion of patients who have logged on to the Predigraft application at least 3 times
Time frame: at 12 months from study inclusion
24 secondary outcomes
French version of Functional, Communicative and Critical Health Literacy (FCCHL) scale
Time frame: at inclusion
French version of Functional, Communicative and Critical Health Literacy (FCCHL)
Time frame: at 12 months after inclusion
Connection time
Time frame: at 12 months after inclusion
Connection frequency
Time frame: at 12 months after inclusion
Time between two connections
Time frame: at 12 months after inclusion
Proportion of fonction used
Time frame: at 12 months after inclusion
Quality of life evaluating using SF36
Time frame: at inclusion
Quality of life evaluating using SF36
Time frame: at 6 weeks
Quality of life evaluated using SF36
Time frame: at 12 months
Medication adherence
Time frame: at inclusion
Medication adherence
Time frame: at 6 weeks
Medication adherence
Time frame: at 12 months
Proportion of hospitalisations
Time frame: at 12 months after inclusion
Proportion of consultations
Time frame: at 12 months after inclusion
Proportion of emergency consultations or hospitalisations
Time frame: at 12 months after inclusion
Overall survival
Time frame: at 12 months after inclusion
Rejection and dialysis free survival
Time frame: at 12 months after inclusion
Cumulative incidence of graft rejection
Time frame: at 12 months after inclusion
Proportion of patients with deteriorated renal function
Time frame: at 12 months after inclusion
Probability of graft survival
Time frame: at inclusion
Probability of graft survival
Time frame: up to 12 months
Probability of graft survival
Time frame: at 12 months
Time from date of graft to date of non-protocol DSA
Time frame: up to 12 months post-inclusion
Time from date of graft to date of non-protocol biopsy
Time frame: up to 12 months post-inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predigraft group in people with Kidney Transplant, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who have logged on to the Predigraft application at least 3 times (time frame: at 12 months from study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.